Viewing Study NCT04661722



Ignite Creation Date: 2024-05-06 @ 3:32 PM
Last Modification Date: 2024-10-26 @ 1:51 PM
Study NCT ID: NCT04661722
Status: UNKNOWN
Last Update Posted: 2021-04-26
First Post: 2020-12-03

Brief Title: A Comparison of the TIMI GRACE HEART and HEARTSIL Scores
Sponsor: Konya Meram State Hospital
Organization: Konya Meram State Hospital

Study Overview

Official Title: Comparison of Prognostic Performance of TIMI GRACE HEART and HEARTSIL SCORES in Patients Admitted to the Emergency Department With Chest Pain
Status: UNKNOWN
Status Verified Date: 2020-12
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Chest pain is one of the most common reasons for emergency admission Chest pain can be caused by many cardiac and noncardiac causes Acute Coronary Syndrome ACS is one of the most im-portant of these etiologies ACS has a high mortality rate but with early diagnosis and related inter-ventions a high rate of prognosis can be improved Therefore early recognition of AKS is impor-tant However the challenge in emergency services is not only to identify patients with high risk for ACS Early detection of low-risk patients is also important for emergency room management These patients should be discharged quickly with minimal examination and treatment The follow-up of these patients with the acceptance of ACS brings along unnecessary examinations and treatments This leads to an increase in healthcare costs and an increase in crowd in emergency services and hospitals

Evaluation of chest pain in the emergency room and early detection of life-threatening conditions such as ACS present many difficulties for clinicians For this reason clinicians use some scoring systems that determine the risk stratification of patients and the probability of having acute coronary syndrome Heart score is one of the scores developed for this purpose However vital signs are not included in calculating the heart score Therefore the investigators considered to include the shock index calcula-ted by systolic blood pressure and pulse in this scoring system In addition the investigators have included a very valuable biochemical parameter such as lactate that predicts mortality in many diseases in this scoring system The investigators named this scoring system HEARTSIL The investigators aim to compare the diagnostic performance of this score with the diagnostic performance of other scoring systems
Detailed Description: The study was planned to be conducted in Konya City Hospital Emergency Service Adult patients over 18 years of age who present to the emergency department with chest pain will be included in the study Patients who do not consent to participate in the study due to chest pain such as ST elevation myocardial infarction pneumonia pneumothorax pulmonary embolism and esophageal rupture will be excluded from the study Vital signs of the patients background information the nature of the pain the drugs used will be recorded Blood tests and electrocardiogram will be recorded Heart Score TIMI GRACE score will be calculated Shock index and lactate value will also be included in the heart score Shock index 05-07 0 points 071-1 1 point and above 1 will be cal-culated as 2 points Lactate levels 0-2 mEqL 0 points between 21-399 mEqL 1 point above 4 mEqL levels will be calculated 2 points These points will be added to the Heart Score and will be named HEARTSIL Patients will be followed in terms of major cardiac events MACE for 3 days and 1 month Prog-nostic performance of HEARTSIL Score Heart Score GRACE TIMI scores that the investigators developed will be compared

The data will be uploaded to the database for statistics First of all whether the data is normally distributed or not will be determined Student-t for normally distributed data Mann-witney-u test for data that are not normally distributed and chi-square will be used for comparing categorical data The ROC curve will be drawn and compared in determining the prognostic performance of scoring systems for MACE development In addition PPD NPD LR and -LR sensitivity and spe-cificities will be calculated Values with a p value below 005 will be considered statistically signifi-cant

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None